Miscellaneous: History of alcohol or drug abuse within the 5 years prior to enrollment; female subjects who are not post-menopausal or surgically sterile who are not using an acceptable method of contraception; male subjects not practicing adequate contraception; breastfeeding patients; unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returing for follow-up visits on schedule; previous participation in this study; and inability to understand/give the informed consent.